Minimal Compared With Standard Monitoring During Sofosbuvir-Based Hepatitis C Treatment: A Randomized Controlled...

Area of Science:

• Hepatology
• Infectious Diseases
• Clinical Trials

Background:

• Oral direct-acting antiviral agents (DAAs) have replaced interferon for hepatitis C virus (HCV) treatment in Australia since 2016.
• The optimal monitoring strategy for patients on DAAs remains undetermined.

Purpose of the Study:

• To compare the efficacy and patient experience of standard versus minimal monitoring schedules in adults receiving sofosbuvir-based HCV therapy.
• To evaluate sustained virological response, staff time, and patient satisfaction.

Main Methods:

• A randomized controlled trial involving adults with HCV genotypes 1 or 3, excluding those with cirrhosis or predicted poor adherence.
• Standard monitoring involved clinic visits and blood tests at weeks 4, 12, and post-treatment.
• Minimal monitoring included phone calls at weeks 4 and 12, with one post-treatment visit and blood test.

Main Results:

• Sustained virological response was high in both groups (89% standard vs. 97% minimal).
• Minimal monitoring significantly reduced blood test costs ($123 vs. $432) and showed comparable patient satisfaction.
• No significant differences were observed in staff time, adverse events, or unplanned hospital visits.

Conclusions:

• On-treatment monitoring with frequent blood tests and clinic visits may not be essential for selected HCV patients on sofosbuvir-based therapy.
• Minimal monitoring is a cost-effective and viable alternative for specific patient populations undergoing HCV treatment.